Fit-for-Purpose Signal Detection Solutions for Pharmacovigilance

Effective pharmacovigilance demands continuous monitoring of drug safety signals, a critical process that ensures accurate benefit-risk assessment while meeting global regulatory requirements. This paper examines the fundamental importance of signal detection methodologies and describes how Qinecsa’s Signal Detection as a Service (QSDaaS) empowers pharmaceutical teams to implement proactive risk management strategies that enhance patient safety and […]

Building an Automation and AI Culture

Written by Martin Holm-Petersen, Chief Strategy Officer Preamble This will be the first in a series of articles about the application of artificial intelligence (AI) and advanced automation in our industry, with a focus on the pharmacovigilance (PV) use-case. The intention of the series of article is to explain the current state of automation and the issues […]

What is Pharmacovigilance?

Pharmacovigilance is a critical component of the medicinal product lifecycle, focusing on ensuring the safety and efficacy of medicinal products from pre-clinical development through post-marketing surveillance. The primary goals of pharmacovigilance are to enhance patient safety, manage risks, and strengthen public health and trust in therapeutic products. Regulatory bodies mandate rigorous vigilance to detect and […]

Integrating Medical Devices into Pharmacovigilance Portfolios

In her latest article for IPI, Qinecsa President, Humaira Qureshi discussed the practical challenges of integrating medical devices into pharmacovigilance portfolios, the obligations of device manufacturers, how to navigate the European Medical Device Regulation, maintaining effective post-market surveillance and managing the life cycle of a medical device. Understanding medical device regulations is essential for pharmacovigilance […]

Shaping the Future of Clinical Research Technology

A head of our first exhibition at the DIA Global Annual Meeting, taking place in San Diego from June 16th-20th, Qinecsa spoke with Outsourcing-Pharma about our latest breakthrough in clinical research technology, how it addresses the current challenges in the industry, and the major trends that will shape the future of pharmaceuticals. You can read the […]

Embracing a new future-ready pharmacovigilance ecosystem

Following her attendance at DIA Europe 2024, Humaira Qureshi, President of Qinecsa Solutions, spoke with PharmaPhorum about the transforming pharmacovigilance landscape, the potential barriers and how organizations can embrace a new future-ready pharmacovigilance ecosystem. “This offers an opportunity to embrace novel technologies, aligned with culture and processes, to demonstrate how pharmacovigilance (PV) can save time, […]

PV Insights Network Benchmarking Report: The dynamics of drug safety in small pharma, biotech, and medical devices

Drug safety is critical to protect patients and consumers exposed to pharmaceutical development and commercialized drugs. Although the principal framework for Drug Safety and PV operation is similar for all small pharma, biotech, and medical device companies, organized collection and analysis of this segment’s PV profile and process is limited. Efficient and effective drug safety […]

PV Insights Network White Paper: Key challenges to address pharmacovigilance needs

Drug safety leaders speak There are thousands of small pharma and biotech companies around the world. Yet when it comes to drug safety, these organizations often struggle to source specialist support that addresses the unique challenges they face. From April to June 2023, we undertook a roundtable series ‘Drug safety in small pharma and biotech’ […]

Fit-for-future sourcing for pharmacovigilance: Embracing Change for Success

Author: Humaira Qureshi, President of Qinecsa Solutions The pharmacovigilance industry is in an unprecedented era of change. PV teams are experiencing year-on-year increases in case volumes, driven in part by increased awareness and reporting by patients. Regulatory agencies are embracing the opportunities provided by innovation and technology, and the rise in methods and formats to […]

Transforming data into decisions

Dr Andrew Rut recently presented at the PV Legal Forum in Chicago on the importance of collecting and analyzing holistic safety data in order to make good decisions for individual patients needing treatments. Disconnected systems lead to gaps and errors in the pharmacovigilance process: There is a lack of information at market authorization as clinical […]